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A Study of NNZ-2591 in Pediatric Participants With Phelan-McDermid Syndrome

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Study sites: 17 to 18
  2. Study sites: 15 to 17
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 6 of 6 entries
  3. Study sites: 14 to 15v9
  4. Study sites: 12 to 14v8
  5. Trial sites expanded: 9 → 12 locationsv7
Show 5 earlier versionsHide 5 earlier versions
  1. Study sites: 7 to 9v6
  2. Study sites: 5 to 7v5
  3. Study sites: 3 to 5v4
  4. Study sites: 2 to 3v3
  5. Study sites: 1 to 2v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This Phase 3, randomized, double-blind, parallel-group (2-arm), placebo-controlled, multicenter study will evaluate the efficacy and safety of NNZ-2591 compared to placebo in pediatric participants with Phelan- McDermid Syndrome.
Trial Details
NCT Number NCT07281079
Lead Sponsor Neuren Pharmaceuticals Limited
Conditions
(from sponsor)		 Phelan-McDermid Syndrome
Related terms Telomeric 22q13 Monosomy Syndrome
Enrollment 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov